Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age

NCT ID: NCT06618196

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-02
• Study Completion Date: 2026-04-30

Brief Summary

This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type B Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Test group 1

Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Group Type: EXPERIMENTAL

LR20062

Intervention Type: BIOLOGICAL

DTaP-HepB-IPV-Hib vaccine

Test group 2

Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Group Type: EXPERIMENTAL

LR20062

Intervention Type: BIOLOGICAL

DTaP-HepB-IPV-Hib vaccine

Test group 3

High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Group Type: EXPERIMENTAL

LR20062

Intervention Type: BIOLOGICAL

DTaP-HepB-IPV-Hib vaccine

Test group 4

Control hexavalent vaccine (DTaP-HepB-IPV-Hib)

Group Type: ACTIVE_COMPARATOR

DTaP-HepB-IPV-Hib vaccine

Intervention Type: BIOLOGICAL

Control hexavalent vaccine

Interventions

LR20062

DTaP-HepB-IPV-Hib vaccine

Intervention Type: BIOLOGICAL

DTaP-HepB-IPV-Hib vaccine

Control hexavalent vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.

2. Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.

Exclusion Criteria

Medical conditions:

1. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.

2. Has a known SARS-CoV-2 infection at Screening.

3. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.

4. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.

5. Had a recent febrile illness, defined as axillary temperature ≥38.0℃ [≥100.4℉] occurring at or within 72 hours prior to receipt of study vaccine.

Prior/concomitant therapy:

6. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.

7. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.

1. Has received systemic corticosteroids (equivalent of ≥0.5 mg/kg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.

2. Is expected to require any systemic corticosteroids during conduct of the study.

Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.

9. Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.

Exception: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.

• Minimum Eligible Age: 50 Days
• Maximum Eligible Age: 70 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Study Lead

Role: CONTACT

lgclinical@lgchem.com

82-2-6987-4427

Other Identifiers

LG-VGCL002

Identifier Type: -

Identifier Source: org_study_id